UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000710 |
|---|---|
| Receipt number | R000000843 |
| Scientific Title | Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604) |
| Date of disclosure of the study information | 2007/05/08 |
| Last modified on | 2015/09/11 14:53:42 |
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Basic information
Public title
Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Acronym
Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Scientific Title
Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Scientific Title:Acronym
Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Region
| Japan |
Condition
Condition
esophageal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I part: to evaluate maximum tolerating dose and dose-limiting toxicities to determine recommended dose of S-1 in combination with a fixed dose of cisplatin and radiotherapy in patients with clinical stage II/III esophageal carcinoma.
Phase II part: to evaluate complete response rate and validate the recommended dose based on frequency and degree of adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence of dose limiting toxicity/Complete response rate
Key secondary outcomes
Adverse event, Overall survival, Progression free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Concurrent chemoradiotherapy with S-1 and cisplatin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage II or III without T4
4) Aged 20 to 70 years old
5) ECOG PS of 0 or1
6) no need for measurable lesion
7) no previous treatment of esophageal cancer
8) no previous chemotherapy or radiotherapy against any other malignancies
9) adequate water intake
10)no palsy of recurrent nerve
11) adequate organ functions
12) refused esophagectomy
13) written informed consent
Key exclusion criteria
1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Patients requiring the administration of phenytoin or warfarin potassium
3) Pregnant or lactating women or women of childbearing potential
4) Psychosis
5) Patients requiring systemic steroids medication
6) HBs antigen positive
7) Uncontrollable diabetes millutus or requiring administration of insulin
8) Uncontrollable hypertension
9) History of myocardial infarction or unstable angina pectoris
10) Interstitial pneumonia, fibroid lung or severe emphysema
11) Active bacterial or fungous infection
Target sample size
81
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atushi Ohtsu, MD, PhD |
Organization
National Cancer Center Hospital East
Division name
Research Center for Innovative Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Tahara, MD, PhD |
Organization
JCOG0604 Coordinating Office
Division name
Outpatient division, National Cancer Center Hospital East
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL
04-7133-1111
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
Funding Source
Organization
Center for Clinical Trials, Japan Medical Association
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
初回届出年月日：2007/4/23, 届出回数：1回
Institutions
Institutions
国立がん研究センター東病院（千葉県）
国立がん研究センター中央病院（東京都）
慶應義塾大学病院（東京都）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26250827
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2007 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000843
